| Device Classification Name |
Syringe, Piston
|
| 510(k) Number |
K881867 |
| Device Name |
NEEDLE EJECTOR |
| Applicant |
| Howard, Hills & Harsh |
| 380 W. Lucy Ave. |
|
Salt Lake City,
UT
84101
|
|
| Applicant Contact |
LINDA R HILLS |
| Correspondent |
| Howard, Hills & Harsh |
| 380 W. Lucy Ave. |
|
Salt Lake City,
UT
84101
|
|
| Correspondent Contact |
LINDA R HILLS |
| Regulation Number | 880.5860 |
| Classification Product Code |
|
| Date Received | 05/03/1988 |
| Decision Date | 11/22/1988 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
General Hospital
|
| 510k Review Panel |
General Hospital
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|